Cleared Traditional

K991073 - ACIER SUTURES

K991073 is an FDA 510(k) clearance for ACIER SUTURES, manufactured by Cardio Thoracic Systems. The device is a Class 2 General & Plastic Surgery device with product code GAQ cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K991073 · Cardio Thoracic Systems · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
121d
Days
Class 2
Risk

K991073 is an FDA 510(k) clearance for the ACIER SUTURES. Classified as Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile (product code GAQ), Class II - Special Controls.

Submitted by Cardio Thoracic Systems (Cupertino, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4495 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Cardio Thoracic Systems devices

FDA 510(k) Submission Details - K991073

510(k) Number K991073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1999
Decision Date July 30, 1999
Days to Decision 121 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAQ Device Classification - Class 2, Special Controls

Product Code GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4495
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

All 16
Devices cleared under the same product code (GAQ) and FDA review panel - the closest regulatory comparables to K991073.
SYNTHES (USA) TITANIUM WIRE
K041333 · Synthes (Usa) · Aug 2004
STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE
K030351 · Cp Medical · Mar 2003
STEELEX STERNUM SET
K023411 · Aesculap, Inc. · Dec 2002
STAINLESS STEEL NONABSORBABLE SURGICAL SUTURE, USP
K984151 · Mill Pond, Inc. · Apr 1999
STAINLESS STEEL SUTURES, FLEXON STEEL SUTURES (STAINLESS)
K955723 · Davis & Geck, Inc. · Feb 1996
STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK
K946173 · Ethicon, Inc. · Jan 1995